Method for delivering radiation to an intraluminal site in the body

• US 6,685,618 B2
• Filed: 08/31/2001
• Issued: 02/03/2004
• Est. Priority Date: 02/19/1998
• Status: Expired due to Fees

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Trauthen, Brett A., Tam, Lisa A.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/944,649
• Publication Number:
  US 20030208096A1
• Time in Patent Office: 886 Days
• Field of Search: 600/1-8, 604/19, 604/53, 604/104, 604/106-107, 604/202, 606/194
• US Class Current: 600/3
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61K 51/1279 Plasters, bandages, dressings, patches or adhesives
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61K 9/1641 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 2005/1005 with asymmetrical radiation pattern
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy
• CPC Class Codes: G03C 5/02 Sensitometric processes, e.g. determining sensitivity, colour sensitivity, gradation, graininess, density; Making sensitometric wedges
• CPC Class Codes: G21G 4/06 characterised by constructional features

Abstract

Disclosed is a thin film radiation source, which may be used to deliver a radioactive dose to a site in a body lumen. The source comprises a thin flexible substrate, and a layer of radioisotope attached thereto. The source may further comprise additional layers such as one or more tie layers disposed between the substrate and the radioisotope layer and one or more outer coating layers. In one embodiment, the source is wrapped around an inflatable balloon. Inflation of the balloon at a treatment site positions the source directly adjacent to the vessel wall, and allows irradiation of the site following or simultaneously with a balloon angioplasty, stent implantation, or stent sizing procedure.

Claims

1. A method of treating a site within a vessel, comprising:

identifying a site in a vessel to be treated;

providing a radiation delivery catheter including an elongate flexible tubular body having an expandable balloon with a thin film radiation delivery layer thereon, said thin film comprising a substrate layer and an isotope layer comprising a metal salt or a metal oxide, and at least one radioactive isotope;

positioning the balloon within the treatment site;

inflating the balloon within the treatment site;

delivering a circumferentially substantially uniform dose of radiation from the delivery balloon to the treatment site;

deflating the balloon; and

removing the balloon with the thin film radiation delivery layer thereon from the treatment site.

2. A method of treating a site within a vessel as in claim 1, wherein said site comprises a previously implanted prosthesis, and positioning the balloon comprises positioning the balloon within the prosthesis.

3. A method of treating a site within a vessel as in claim 2, wherein the prosthesis comprises a stent or graft.

4. A method of treating a site within a vessel as in claim 1, wherein said isotope is a gamma or beta emitting isotope.

5. A method of treating a site within a vessel as in claim 1, wherein the radioactive isotope comprises an isotope selected from the group consisting of P-32, I-125, Pd-103, W/Re-188, As-73, and Gd-153.

6. A method of treating a site within a vessel as in claim 1, wherein the radiation delivery layer further comprises a tie layer disposed between the support layer and the isotope layer.

7. A method of treating a site within a vessel as in claim 1, wherein the radiation delivery layer further comprises a coating layer upon the isotope layer.

8. A method of treating a site within a vessel as in claim 7, wherein said coating layer comprises a material selected from the group consisting of cyanoacrylates, acrylics, acrylates, acrylic acid, urethanes, polybutyl vinyl chloride, and polyvinylidine chloride.

9. A method of treating a site within a vessel as in claim 1, further comprising perfusing blood from a proximal side of the balloon to a distal side of the balloon while the balloon is inflated.

10. A method of treating a site within a vessel as in claim 1, wherein the catheter further comprises a proximal guide wire access port on the tubular body, positioned distally of the proximal end of the tubular body.

11. A method of delivering a dose of radiation to a lumen, comprising:

providing a radiation delivery catheter including an elongate flexible tubular body having a radiation delivery layer carried by an expandable support on the tubular body, said radiation delivery layer comprising a substrate layer and an isotope layer comprising a metal salt or a metal oxide, and at least one radioactive isotope;

positioning the expandable support within the lumen;

radially expanding the support within the lumen;

delivering a circumferentially substantially uniform dose of radiation to the lumen in the region of the radiation delivery layer;

radially contracting the support; and

removing the support and the radiation delivery layer from the lumen.

12. A method as in claim 11, wherein radially expanding the support comprises inflating an inflatable balloon.

13. A method as in claim 11, further comprising perfusing blood from a proximal side of the expandable support to a distal side of the expandable support while the support is expanded.

14. A method of treating a site within a vessel as in claim 11, wherein said isotope is a gamma or beta emitting isotope.

15. A method as in claim 11, wherein the radioactive isotope comprises an isotope selected from the group consisting of P-32, I-125, Pd-103, W/Re-188, As-73, and Gd-153.

16. A method as in claim 11, wherein the radiation delivery layer further comprises a tie layer disposed between the support layer and the isotope layer.

17. A method as in claim 11, wherein the radiation delivery layer further comprises a coating layer upon the isotope layer.

18. A method as in claim 17, wherein said coating layer comprises a material selected from the group consisting of cyanoacrylates, acrylics, acrylates, acrylic acid, urethanes, polybutyl vinyl chloride, and polyvinylidine chloride.

19. A method as in claim 11, wherein the catheter further comprises a proximal guide wire access port on the tubular body, positioned distally of the proximal end of the tubular body.

20. A method as in claim 11, wherein the substrate layer is integral with the support.

21. A method as in claim 11, wherein the substrate layer is layered upon the support.

22. A method as in claim 11, wherein positioning the support comprises positioning the isotope layer within a stent.

23. A method as in claim 11, wherein the lumen is selected from the group consisting of large and small arteries, large and small veins, hollow organs, surgically created pathways, esophagus, trachea, urethra, ureters, fallopian tubes, intestines and colon.

24. A method of simultaneously performing balloon dilatation of a stenosis in a body lumen and delivering radiation to the body lumen, comprising:

identifying a stenosis in a body lumen;

providing a treatment catheter having an elongate flexible tubular body having an expandable balloon with a thin film radiation delivery layer thereon, said thin film comprising a substrate layer and an isotope layer comprising a metal salt or a metal oxide, and at least one radioactive isotope;

percutaneously inserting and transluminally advancing the balloon through the vessel;

positioning the balloon within the stenosis;

inflating the balloon to radially expand the vessel in the area of the stenosis;

simultaneously delivering radiation from the thin film to the vessel wall; and

removing the balloon with the radiation delivery layer thereon from the stenosis.

25. A method of simultaneously delivering a stent and radiation to a treatment site in body lumen, comprising:

identifying a treatment site in a body lumen;

providing a treatment catheter having an elongate flexible tubular body having a radially expandable support with a thin film radiation delivery layer thereon and an expandable stent carried by the expandable support, said thin film comprising a substrate layer and an isotope layer comprising a metal salt or a metal oxide, and at least one radioactive isotope;

positioning the support at the treatment site in the lumen;

radially expanding the support to expand and deliver the stent;

simultaneously delivering radiation from the thin film to the lumen wall; and

removing the support and thin film from the treatment site.